Blood PressureNCT06019910
Snus and Home Blood Pressure
A study testing Snus with or without tobacco in people with Blood Pressure and Dyslipidemias, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Snus is a type of snuff that is administered sublabially, that has not been studied regarding the effects on home blood pressure and metabolism on a longer time frame. The primary aim of this study is to evaluate the effect of snus on home BP within weeks to months in former snus users who continue to not use snus or… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Dyslipidemias, Dysglycemia
- What is being tested?
- Snus with or without tobacco
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- 9 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- daily use (defined as at least once daily for at least 1 month) o snus
- the ability to use online questionnaires written and answered in Swedish
Who cannot join
- simultaneous use of any other nicotine or tobacco product (including cigarette smoking, e-cigarettes, and nicotine replacement therapy)
- drug use (including cannabis)
- alcohol dependence
- known cardiovascular disease (including hypertension, previous myocardial infarction, stroke, peripheral arterial disease, or angina pectoris), kidney disease, hormonal disease (including diabetes mellitus) or eating disorder
- current or planned pregnancy.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Primary Health Care Center Cityhälsan Centrum
Norrköping
Peder af Geijerstam, MD, peder.af.geijerstam@liu.se
About this study
Official title: The Effects of Snus on Home Blood Pressure and Metabolism
Snus is a type of snuff that is administered sublabially, that has not been studied regarding the effects on home blood pressure and metabolism on a longer time frame. The primary aim of this study is to evaluate the effect of snus on home BP within weeks to months in former snus users who continue to not use snus or relapse in daily snus use, respectively. The secondary aim is to evaluate the effects on metabolic measurements. The hypothesis is that BP will increase amongst the participants that resume snus intake.
28 healthy volunteers with a pre-existing daily use of snus will be recruited and followed during snus cessation. Home blood pressure, lipid and metabolic markers will be measured before and after snus cessation, as well as after snus relapse if such a relapse occurs.
Read the detailed description
Both elevated blood pressure (BP) and cigarette smoking increases the risk of cardiovascular disease. Nicotine, through effects on the nervous system and catecholamine release, increases BP and heart rate, peaking 5-10 minutes after exposure, after which tolerance to nicotine reduces its hemodynamic effects. Smoking also increases energy expenditure, but studies on smoking and long-term metabolism have shown conflicting results.
Snus is a type of snuff that is administered sublabially, that has not been studied regarding the effects on home blood pressure and metabolism on a longer time frame. The primary aim of this study is to evaluate the effect of snus on home BP within weeks to months in former snus users who continue to not use snus or relapse in daily snus use, respectively. The secondary aim is to evaluate the effects on metabolic measurements. The hypothesis is that BP will increase amongst the participants that resume snus intake.
28 healthy volunteers with a pre-existing daily use of snus will be recruited and followed during snus cessation for 3 months. Home blood pressure, lipid and metabolic markers will be measured before and after snus cessation. Furthermore, for participants which relapse in snus use, the same measurements will be followed for an additional 3 months. Home blood pressure will be measured daily, and participants will also report the amount of snus use each day. At week 0, 4 and 12 of snus cessation and snus relapse, the following measurements will also be made: body weight as well as plasma glucose, blood glycated hemoglobin (HbA1c), serum insulin, plasma lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglycerides), plasma hsCRP, plasma creatinine, plasma sodium, and plasma potassium.
As reimbursement, participants will receive (at least) 1000 Swedish krona (Approx 94 US dollar) for the drawing of blood tests. All participants will give written, informed consent prior to participation. The study will comply with the declaration of Helsinki and be approved by the Swedish Ethical Review Authority. Prior to commencement, the study will be registered at ClinicalTrials.gov.
- Conditions
- Blood Pressure, Dyslipidemias, Dysglycemia, Obesity
- Being tested
- Snus with or without tobacco
- Medical subject headings
- Dyslipidemias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snus with or without tobaccoOther
At baseline, participants have used the intervention daily for at least 30 days. They will then cease usage of the intervention abruptly. After 3 weeks, they may continue to abstain from the intervention or relapse at their own discretion.
| Study group | Role | What they receive |
|---|---|---|
| Snus with or without tobacco | Experimental | Snus cessation followed by potential snus relapse Receives: Other: Snus with or without tobacco |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home blood pressure during snus cessation
Change in home blood pressure from baseline until week 4 and week 12 respectively
Measured: 4-12 weeks
Home blood pressure during snus relapse
Change in home blood pressure from week 0 of snus relapse until week 4 and week 12 respectively
Measured: 4-12 weeks
Secondary outcomes (10)
Body weight during snus cessation
Change in body weight from baseline until week 4 and week 12 respectively
Measured: 4-12 weeks
Concentration of plasma lipids during snus cessation
Change in plasma lipids from baseline until week 4 and week 12 respectively
Measured: 4-12 weeks
Concentration of fasting plasma glucose during snus cessation
Change in fasting plasma glucose from baseline until week 4 and week 12 respectively
Measured: 4-12 weeks
Concentration of fasting plasma insulin during snus cessation
Change in fasting plasma insulin from baseline until week 4 and week 12 respectively
Measured: 4-12 weeks
Concentration of blood HbA1c during snus cessation
Change in blood HbA1c from baseline until week 4 and week 12 respectively
Measured: 4-12 weeks
Body weight during snus relapse
Change in body weight from week 0 of snus relapse until week 4 and week 12 respectively
Measured: 4-12 weeks
Concentration of plasma lipids during snus relapse
Change in plasma lipids from week 0 of snus relapse until week 4 and week 12 respectively
Measured: 4-12 weeks
Concentration of fasting plasma glucose during snus relapse
Change in fasting plasma glucose from week 0 of snus relapse until week 4 and week 12 respectively
Measured: 4-12 weeks
Concentration of fasting plasma insulin during snus relapse
Change in fasting plasma insulin from week 0 of snus relapse until week 4 and week 12 respectively
Measured: 4-12 weeks
Concentration of blood HbA1c during snus relapse
Change in blood HbA1c from week 0 of snus relapse until week 4 and week 12 respectively
Measured: 4-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start9 Oct 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- At baseline, all participants use snus, and will be asked to quit their usage. They will then be followed for up to 12 weeks. If and when they relapse in snus use, another 12 weeks will commence, during which the same measurements will repeated but for a second period of up to 12 weeks.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik H Nystrom, University Hospital, Linkoeping
- Investigators
- Fredrik H Nyström, PhD, MD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019910
- Sponsor's protocol ID
- snus2023
- Status last verified
- Apr 2024
- First submitted
- 30 Jul 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; Authors/Task Force Members:. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018 Oct;36(10):1953-2041. doi: 10.1097/HJH.0000000000001940.
PubMed 30234752Benowitz NL, Pipe A, West R, Hays JT, Tonstad S, McRae T, Lawrence D, St Aubin L, Anthenelli RM. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):622-631. doi: 10.1001/jamainternmed.2018.0397.
PubMed 29630702Middlekauff HR, Park J, Moheimani RS. Adverse effects of cigarette and noncigarette smoke exposure on the autonomic nervous system: mechanisms and implications for cardiovascular risk. J Am Coll Cardiol. 2014 Oct 21;64(16):1740-50. doi: 10.1016/j.jacc.2014.06.1201.
PubMed 25323263Martinez-Morata I, Sanchez TR, Shimbo D, Navas-Acien A. Electronic Cigarette Use and Blood Pressure Endpoints: a Systematic Review. Curr Hypertens Rep. 2020 Nov 23;23(1):2. doi: 10.1007/s11906-020-01119-0.
PubMed 33230755Audrain-McGovern J, Benowitz NL. Cigarette smoking, nicotine, and body weight. Clin Pharmacol Ther. 2011 Jul;90(1):164-8. doi: 10.1038/clpt.2011.105. Epub 2011 Jun 1. No abstract available.
PubMed 21633341Chiolero A, Faeh D, Paccaud F, Cornuz J. Consequences of smoking for body weight, body fat distribution, and insulin resistance. Am J Clin Nutr. 2008 Apr;87(4):801-9. doi: 10.1093/ajcn/87.4.801.
PubMed 18400700Hofstetter A, Schutz Y, Jequier E, Wahren J. Increased 24-hour energy expenditure in cigarette smokers. N Engl J Med. 1986 Jan 9;314(2):79-82. doi: 10.1056/NEJM198601093140204.
PubMed 3941694Af Geijerstam P, Joelsson A, Radholm K, Nystrom FH. Cardiovascular and metabolic changes following 12 weeks of tobacco and nicotine pouch cessation: a Swedish cohort study. Harm Reduct J. 2025 Apr 16;22(1):54. doi: 10.1186/s12954-025-01195-y.
PubMed 40241094
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Snus on Home Blood Pressure and Metabolism
- ClinicalTrials.gov ID
- NCT06019910
- Acronym / sponsor ID
- snus2023
- Conditions
- Blood Pressure, Dyslipidemias, Dysglycemia, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Snus is a type of snuff that is administered sublabially, that has not been studied regarding the effects on home blood pressure and metabolism on a longer time frame. The primary aim of this study is to evaluate the effect of snus on home BP within weeks to months in former snus users who continue to not use snus or relapse in daily snus use, respectively. The secondary aim is to evaluate the effects on metabolic measurements. The hypothesis is that BP will increase amongst the participants that resume snus intake.
28 healthy volunteers with a pre-existing daily use of snus will be recruited and followed during snus cessation. Home blood pressure, lipid and metabolic markers will be measured before and after snus cessation, as well as after snus relapse if such a relapse occurs.
Detailed description
Both elevated blood pressure (BP) and cigarette smoking increases the risk of cardiovascular disease. Nicotine, through effects on the nervous system and catecholamine release, increases BP and heart rate, peaking 5-10 minutes after exposure, after which tolerance to nicotine reduces its hemodynamic effects. Smoking also increases energy expenditure, but studies on smoking and long-term metabolism have shown conflicting results.
Snus is a type of snuff that is administered sublabially, that has not been studied regarding the effects on home blood pressure and metabolism on a longer time frame. The primary aim of this study is to evaluate the effect of snus on home BP within weeks to months in former snus users who continue to not use snus or relapse in daily snus use, respectively. The secondary aim is to evaluate the effects on metabolic measurements. The hypothesis is that BP will increase amongst the participants that resume snus intake.
28 healthy volunteers with a pre-existing daily use of snus will be recruited and followed during snus cessation for 3 months. Home blood pressure, lipid and metabolic markers will be measured before and after snus cessation. Furthermore, for participants which relapse in snus use, the same measurements will be followed for an additional 3 months. Home blood pressure will be measured daily, and participants will also report the amount of snus use each day. At week 0, 4 and 12 of snus cessation and snus relapse, the following measurements will also be made: body weight as well as plasma glucose, blood glycated hemoglobin (HbA1c), serum insulin, plasma lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglycerides), plasma hsCRP, plasma creatinine, plasma sodium, and plasma potassium.
As reimbursement, participants will receive (at least) 1000 Swedish krona (Approx 94 US dollar) for the drawing of blood tests. All participants will give written, informed consent prior to participation. The study will comply with the declaration of Helsinki and be approved by the Swedish Ethical Review Authority. Prior to commencement, the study will be registered at ClinicalTrials.gov.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- At baseline, all participants use snus, and will be asked to quit their usage. They will then be followed for up to 12 weeks. If and when they relapse in snus use, another 12 weeks will commence, during which the same measurements will repeated but for a second period of up to 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Snus with or without tobacco | Experimental | Other: Snus with or without tobaccoSnus cessation followed by potential snus relapse |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- daily use (defined as at least once daily for at least 1 month) o snus
- the ability to use online questionnaires written and answered in Swedish
Key exclusion criteria (5 listed)
- simultaneous use of any other nicotine or tobacco product (including cigarette smoking, e-cigarettes, and nicotine replacement therapy)
- drug use (including cannabis)
- alcohol dependence
- known cardiovascular disease (including hypertension, previous myocardial infarction, stroke, peripheral arterial disease, or angina pectoris), kidney disease, hormonal disease (including diabetes mellitus) or eating disorder
- current or planned pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snus with or without tobaccoAt baseline, participants have used the intervention daily for at least 30 days. They will then cease usage of the intervention abruptly. After 3 weeks, they may continue to abstain from the intervention or relapse at their own discretion. | Other | Snus with or without tobacco |
Primary outcome
Home blood pressure during snus cessation
Time frame: 4-12 weeks
Change in home blood pressure from baseline until week 4 and week 12 respectively
Home blood pressure during snus relapse
Time frame: 4-12 weeks
Change in home blood pressure from week 0 of snus relapse until week 4 and week 12 respectively
10 secondary outcomes
Body weight during snus cessation
Time frame: 4-12 weeks
Concentration of plasma lipids during snus cessation
Time frame: 4-12 weeks
Concentration of fasting plasma glucose during snus cessation
Time frame: 4-12 weeks
Concentration of fasting plasma insulin during snus cessation
Time frame: 4-12 weeks
Concentration of blood HbA1c during snus cessation
Time frame: 4-12 weeks
Body weight during snus relapse
Time frame: 4-12 weeks
Concentration of plasma lipids during snus relapse
Time frame: 4-12 weeks
Concentration of fasting plasma glucose during snus relapse
Time frame: 4-12 weeks
Concentration of fasting plasma insulin during snus relapse
Time frame: 4-12 weeks
Concentration of blood HbA1c during snus relapse
Time frame: 4-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Background: PubMed 30234752Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; Authors/Task Force Members:. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018 Oct;36(10):1953-2041. doi: 10.1097/HJH.0000000000001940.
- Background: PubMed 29630702Benowitz NL, Pipe A, West R, Hays JT, Tonstad S, McRae T, Lawrence D, St Aubin L, Anthenelli RM. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):622-631. doi: 10.1001/jamainternmed.2018.0397.
- Background: PubMed 25323263Middlekauff HR, Park J, Moheimani RS. Adverse effects of cigarette and noncigarette smoke exposure on the autonomic nervous system: mechanisms and implications for cardiovascular risk. J Am Coll Cardiol. 2014 Oct 21;64(16):1740-50. doi: 10.1016/j.jacc.2014.06.1201.
- Background: PubMed 33230755Martinez-Morata I, Sanchez TR, Shimbo D, Navas-Acien A. Electronic Cigarette Use and Blood Pressure Endpoints: a Systematic Review. Curr Hypertens Rep. 2020 Nov 23;23(1):2. doi: 10.1007/s11906-020-01119-0.
- Background: PubMed 21633341Audrain-McGovern J, Benowitz NL. Cigarette smoking, nicotine, and body weight. Clin Pharmacol Ther. 2011 Jul;90(1):164-8. doi: 10.1038/clpt.2011.105. Epub 2011 Jun 1. No abstract available.
- Background: PubMed 18400700Chiolero A, Faeh D, Paccaud F, Cornuz J. Consequences of smoking for body weight, body fat distribution, and insulin resistance. Am J Clin Nutr. 2008 Apr;87(4):801-9. doi: 10.1093/ajcn/87.4.801.
- Background: PubMed 3941694Hofstetter A, Schutz Y, Jequier E, Wahren J. Increased 24-hour energy expenditure in cigarette smokers. N Engl J Med. 1986 Jan 9;314(2):79-82. doi: 10.1056/NEJM198601093140204.
- Derived from this study: PubMed 40241094Af Geijerstam P, Joelsson A, Radholm K, Nystrom FH. Cardiovascular and metabolic changes following 12 weeks of tobacco and nicotine pouch cessation: a Swedish cohort study. Harm Reduct J. 2025 Apr 16;22(1):54. doi: 10.1186/s12954-025-01195-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrik H Nyström, PhD, MD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snus with or without tobacco in people with Blood Pressure and Dyslipidemias, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peder af Geijerstam, MD (+460739597426, peder.af.geijerstam@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home blood pressure during snus cessation (time frame: 4-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06019910, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.